FDA product code NYK: Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma)
NYK is the FDA product code for ophthalmodynamometer, diagnostic contact lens, polymethylmethacrylate (pmma). It is a Class II device, regulated under 21 CFR 886.1385 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under NYK. The average 510(k) review took 239 days (median 239).
Definition
Pmma diagnostic contact lens ophthalmodynamometer is intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis of intraocular abnormalities. The device is indicated for examination of the ocular fundus, vitreous and retinal structures, while manually applying force to the eye with the contact lens. The device measures and displays the amount of force that is applied to the eye.
Classification
| Field | Value |
|---|---|
| Device name | Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (Pmma) |
| Device class | Class II |
| Regulation | 21 CFR 886.1385 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NYK clearance
Top NYK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meditron, GmbH | 1 | 2006-05-24 |
Most recent NYK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052674 | Meditron, GmbH | CONTACT LENS OPHTHALMODYNAMOMETER | 2006-05-24 | 239 |
Recalls for NYK devices
openFDA lists no recalls for product code NYK.
Frequently asked questions
What is FDA product code NYK?
NYK is the FDA product code for ophthalmodynamometer, diagnostic contact lens, polymethylmethacrylate (pmma). It is a Class II device, regulated under 21 CFR 886.1385 and reviewed by the Ophthalmic panel.
What device class is NYK?
Class II, regulation 21 CFR 886.1385. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYK?
Across 1 cleared submissions the average was 239 days from receipt to decision (median 239).
Which companies have the most NYK clearances?
Meditron, GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NYK
- Run a recall and safety report across every NYK manufacturer
- Watch product code NYK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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